Supportive Care in Cancer

, Volume 18, Issue 11, pp 1437–1444 | Cite as

Casopitant improves the quality of life in patients receiving highly emetogenic chemotherapy

  • Cesare Gridelli
  • Amin M. Haiderali
  • Mark W. Russo
  • Linda M. Blackburn
  • Konstantinos Lykopoulos
Original Article

Abstract

Purpose

The control of chemotherapy-induced nausea and vomiting (CINV) is critical in preventing poor health outcomes and increasing patient quality of life. The objective of this study was to evaluate the impact of the addition of casopitant to dual-combination therapy of dexamethasone and ondansetron on quality of life in patients receiving highly emetogenic chemotherapy (HEC).

Methods

In a multicenter, double-blind, randomized, placebo-controlled, add-on trial (N = 810), patients were randomized to intravenous (IV) ondansetron/dexamethasone alone (control) or in combination with either a single 150-mg oral dose of casopitant or 3-day IV/oral casopitant. Quality of life was assessed as impact of nausea and vomiting on daily life using the Functional Living Index Emesis (FLIE) questionnaire. Patients completed the FLIE questionnaire at baseline prior to receiving chemotherapy and after completion of the first cycle of HEC.

Results

Patients in the single oral dose and 3-day IV/oral casopitant groups scored higher mean total FLIE scores (115.7 and 114.0, respectively; p ≤ 0.0332) than patients in the control group (107.5), indicating that casopitant patients experienced less impact from nausea and vomiting on daily life. The overall absolute difference in the proportion of patients reporting CINV with no impact on daily life between the single oral casopitant group and the control group was 13%; the difference between the 3-day IV/oral casopitant group and the control group was 14%.

Conclusion

The addition of casopitant to ondansetron and dexamethasone in patients receiving HEC was significantly more effective in reducing the impact of nausea and vomiting on all daily life activities as assessed by the FLIE compared with ondansetron/dexamethasone dual therapy.

Keywords

Casopitant Highly emetogenic chemotherapy Quality of life Functional Living Index Emesis (FLIE) questionnaire 

Notes

Acknowledgments

The authors acknowledge Kim Poinsett-Holmes, PharmD (Poinsett Publications, Inc.), for her editorial assistance with the submitted manuscript. This study was supported by a research grant from GlaxoSmithKline.

References

  1. 1.
    Sun CC, Bodurka DC, Weaver CB, Rasu R, Wolf JK, Bevers MW, Smith JA, Wharton JT, Rubenstein EB (2005) Rankings and symptom assessments of side effects from chemotherapy: insights from experienced patients with ovarian cancer. Support Care Cancer 13:219–227CrossRefPubMedGoogle Scholar
  2. 2.
    Richardson JL, Marks G, Levine A (1988) The influence of symptoms of disease and side effects of treatment on compliance with cancer therapy. J Clin Oncol 6:1746–1752PubMedGoogle Scholar
  3. 3.
    Schnell FM (2003) Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. Oncologist 8:187–198CrossRefPubMedGoogle Scholar
  4. 4.
    Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H (2007) Chemotherapy-induced nausea and vomiting—incidence and impact on patient quality of life at community oncology settings. Support Care Cancer 15:497–503CrossRefPubMedGoogle Scholar
  5. 5.
    Voliotis DL, Diehl V (1998) Clinical aspects and prognostic factors of nausea and vomiting after chemotherapy. In: DiCato MA (ed) Medical management of cancer treatment induced emesis. Martin Dunitz, Philadelphia, pp 45–54Google Scholar
  6. 6.
    Hesketh PJ, Harvey WH, Harker WG, Beck TM, Ryan T, Bricker LJ, Kish JA, Murphy WK, Hainsworth JD, Haley B (1994) A randomized, double-blind comparison of intravenous ondansetron alone and in combination with intravenous dexamethasone in the prevention of high-dose cisplatin-induced emesis. J Clin Oncol 12:596–600PubMedGoogle Scholar
  7. 7.
    Dibble SL, Isreal J, Nussey B, Casey K, Luce J (2003) Delayed chemotherapy-induced nausea in women treated for breast cancer. Oncol Nurs Forum 30:E40–E47CrossRefPubMedGoogle Scholar
  8. 8.
    Grunberg SM, Deuson RR, Mavros P, Geling O, Hansen M, Cruciani G, Daniele B, De Pouvourville G, Rubenstein EB, Daugaard G (2004) Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer 100(10):2261–2268CrossRefPubMedGoogle Scholar
  9. 9.
    Hickock JT, Roscoe JA, Morrow GR, King DK, Atkins JN, Fitch TR (2003) Nausea and emesis remain significant problems of chemotherapy despite prophylaxis with 5-hydroxytriptamine-3 antiemetics: a University of Rochester James P. Wilmot Cancer Center Community Clinical Oncology Program Study of 360 cancer patients treated in the community. Cancer 97:2880–2886CrossRefGoogle Scholar
  10. 10.
    Hesketh PJ, Gralla RJ, Webb RT, Ueno W, Delprete S, Bachinski ME, Dirlam NL, Stack CB, Silberman SL (1999) Randomized phase II study of the neurokinin I receptor antagonist CJ-11, 974 in the control of cisplatin-induced emesis. J Clin Oncol 1791:338–343Google Scholar
  11. 11.
    Navari RM, Reinhart RR, Gralla RJ, Kris MG, Hesketh PJ, Kojasteh A, Kindler H, Grote TH, Pendergrass K, Grunberg SM, Carides AD, Gertz BJ (1999) Reduction of cisplatin-induced emesis by a selective neurokinin-1-receptor antagonist. N Engl J Med 340:190–195CrossRefPubMedGoogle Scholar
  12. 12.
    Cocquyt V, Van Belle S, Reinhardt RR, Decramer ML, O’Brien M, Schellens JH, Borms M, Verbeke L, Van Aelst F, De Smet M, Carides A, Eldridge K, Gertz BJ (2001) Comparison of L-758, 298, a prodrug for the selective neurokinin-1 antagonist, L-754, 030, with ondansetron for the prevention of cisplatin-induced emesis. Eur J Cancer 37:835–842CrossRefPubMedGoogle Scholar
  13. 13.
    Horgan KJ, Eldridge KN, Carides A, Van Belle S, Hesketh PJ (2001) Differential time course of cisplatin induced acute emesis with a 5HT3 antagonist or an NK1 antagonist: rationale for combination therapy. Proc ASCO 20:383a AbstractGoogle Scholar
  14. 14.
    Grunberg SM, Rolski J, Strausz J, Aziz Z, Lane S, Russo MW, Wissel P, Guckert M, Wright O, Herrstedt J (2009) Efficacy and safety of casopitant mesylate, a neurokinin 1 (NK1)-receptor antagonist, in prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled trial. Lancet Oncol 10:549–558CrossRefPubMedGoogle Scholar
  15. 15.
    Martin AR, Carides AD, Pearson JD, Horgan K, Elmer M, Schmidt C, Cai B, Sp C, Grunberg SM (2003) Functional relevance of antiemetic control: experience using the FLIE questionnaire in a randomized study of the NK-1 antagonist aprepitant. Eur J Cancer 39:1395–1401CrossRefPubMedGoogle Scholar
  16. 16.
    Decker GM, DeMeyer ES, Kisko DL (2006) Measuring the maintenance of daily life activities using the functional living index-emesis (FLIE) in patients receiving moderately emetogenic chemotherapy. J Support Oncol 4:35–52PubMedGoogle Scholar
  17. 17.
    Bliss JM, Robertson B, Selby PJ (1992) The impact of nausea and vomiting upon quality of life measures. Br J Cancer Suppl 19:S14–S22PubMedGoogle Scholar
  18. 18.
    Lindley CM, Hirsch JD, O’Neill CV, Transau MC, Gilbert CS, Osterhaus JT (1992) Quality of life consequences of chemotherapy-induced emesis. Qual Life Res 1:331–340CrossRefPubMedGoogle Scholar
  19. 19.
    O’Brien BJ, Rusthoven J, Rocchi A, Latreille J, Fine S, Vandenberg T, Laberge F (1993) Impact of chemotherapy-associated nausea and vomiting on patients’ functional status and on costs: survey of five Canadian centres. CMAJ 149:296–302PubMedGoogle Scholar
  20. 20.
    Ballatori E, Roila F, Ruggeri B, Betti M, Sarti S, Soru G, Cruciani G, Di Maio M, Andrea B, Deuson RR (2007) The impact of chemotherapy-induced nausea and vomiting on health-related quality of life. Support Care Cancer 15:179–185CrossRefPubMedGoogle Scholar
  21. 21.
    Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM (2006) American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol 24:2932–2947CrossRefPubMedGoogle Scholar
  22. 22.
    National Comprehensive Cancer Network. Clinical practice guidelines in oncology. http://www.nccn.org/professionals/physician_gls/PDF/antiemesis.pdf. Accessed 1 August 2008
  23. 23.
    Roila F, Hesketh PJ, Herrstedt J (2006) Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol 17:20–28CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Cesare Gridelli
    • 1
  • Amin M. Haiderali
    • 2
  • Mark W. Russo
    • 2
  • Linda M. Blackburn
    • 2
  • Konstantinos Lykopoulos
    • 3
  1. 1.Division of Medical Oncology“S.G. Moscati” HospitalAvellinoItaly
  2. 2.GlaxoSmithKlineCollegevilleUSA
  3. 3.GlaxoSmithKlineLondonUK

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